FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37753–37776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2014
SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
K140517 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 59d
Cleared Apr 28, 2014
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · MTD
Boston Scientific Corporation
Cardiovascular · 35d
Cleared Apr 28, 2014
CAIMAN SEAL AND CUT TECHNOLOGY
K140839 · GEI
Aesculap, Inc.
General & Plastic Surgery · 26d
Cleared Apr 25, 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · MAX
Exactech, Inc.
Orthopedic · 520d
Cleared Apr 25, 2014
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
K131946 · EOQ
Pentax Medical Company
Ear, Nose, Throat · 302d
Cleared Apr 25, 2014
THE MOSES ELITE APPLIANCE
K132933 · LRK
Allen J. Moses, Dds, Ltd.
Dental · 219d
Cleared Apr 25, 2014
GEL-BEAD EMBOLIZATION SPHERES
K133237 · KRD
Vascular Solutions, Inc.
Cardiovascular · 186d
Cleared Apr 25, 2014
FORA CARE BLOOD PRESSURE MONITORING SYSTEM
K133588 · DXN
Foracare, Inc.
Cardiovascular · 155d
Cleared Apr 25, 2014
SMARTTOUCH
K133951 · CAF
Nexus6, Ltd.
Anesthesiology · 123d
Cleared Apr 25, 2014
2300 SERIES MGO PORTABLE OXYGEN
K134023 · CAW
Ultra Electronics Limited Precision...
Anesthesiology · 116d
Cleared Apr 25, 2014
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR...
K134045 · NHA
Zimmer Dental, Inc.
Dental · 115d
Cleared Apr 25, 2014
EASY GO VAC
K140179 · BTA
Precision Medical, Inc.
General & Plastic Surgery · 91d
Cleared Apr 25, 2014
MTA FILLAPEX
K140247 · KIF
Angelus Industria DE Productos...
Dental · 85d
Cleared Apr 25, 2014
PINIT SMALL BONE FUSION SYSTEM
K140617 · HRS
Arthrosurface, Inc.
Orthopedic · 45d
Cleared Apr 25, 2014
MYLABSSOGNO
K140677 · IYN
Esaote, S.P.A.
Radiology · 38d
Cleared Apr 25, 2014
RELIANCE ANTERIOR CERVICAL PLATE
K140742 · KWQ
Reliance Medical Systems, LLC
Orthopedic · 31d
Cleared Apr 25, 2014
INFINITY TOTAL ANKLE SYSTEM
K140749 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared Apr 25, 2014
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
K140764 · JJY
Bio-Rad Laboratories
Immunology · 29d
Cleared Apr 25, 2014
PHILIPS ELEVA WORKSPOT
K140771 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 29d
Cleared Apr 25, 2014
TERASON USMART3400 ULTRASOUND SYSTEM
K140834 · IYN
Teratech Corp.
Radiology · 23d
Cleared Apr 25, 2014
INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR...
K140851 · OEP
Centers For Disease Control and...
Microbiology · 22d
Cleared Apr 25, 2014
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME...
K140857 · OZE
Centers For Disease Control and...
Microbiology · 22d
Cleared Apr 24, 2014
NEURAGEN 3D
K130557 · JXI
Integra LifeSciences Corporation
Neurology · 416d
Cleared Apr 24, 2014
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K131525 · MKJ
Defibtech, LLC
Cardiovascular · 331d